News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Sleek ‘Lab in a Needle’ Is an All-in-One Device That Detects Liver Toxicity in Minutes during a Study, Showing Potential to Supplant Some Medical Laboratory Tests

Researchers’ prototype uses lab-on-a-chip technology and seems to do it all, from collection and analysis to results in minutes and in the palm of your hand

Here’s a diagnostic workhorse that can also easily slip inside the pocket of a doctor’s white coat. The slim device, created and reported by researchers, integrates a clinical laboratory’s workflow from collecting samples to analyzing them and reporting results in minutes.

The device is dubbed “lab in a needle” by researchers at Houston Methodist and their collaborators at Singapore’s Nanyang Technological University (NTU) and the Singapore Institute of Manufacturing Technology (SIMTech). The recently announced study focused on liver toxicity. But the research team says in a news statement that their medical laboratory-in-a-needle has potential to diagnose and monitor therapies for many health conditions in settings well beyond the medical laboratory and hospital.

For clinical laboratory leaders and pathologists, the prototype can be seen as another step forward in efforts to develop more sophisticated point-of-care testing (POCT) that incorporate miniature lab-on-a-chip (LOC) technologies. Mass production could bring the tiny mobile lab’s capabilities to remote and rural communities where low cost and ease of use are essential. (more…)

Enforcement of FDA’s Unique Device Identification Law Begins as Hospitals, ASCs, and Nursing Homes Must Now Report Adverse Patient Events from High-Risk Medical Devices

Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules

Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device.

The primary goal of the new regulation is to have specified providers report patient deaths that involved high-risk medical devices, such as stents and heart valves, for example. Specified facilities include hospitals, ambulatory surgery centers, and nursing homes. Manufacturers must also report adverse patient events involving their Class III medical devices.

All Class III in vitro diagnostic systems used by clinical laboratories and pathology groups here in the United States will now have a UDI label. (more…)

FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label

Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.

UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)

New iPhone App Allows Consumers to Test Their Urine on the Go for as Many as 25 Different Diseases

Pathologists and clinical laboratory managers may want to learn more about the UCheck mobile app developed by Biosense Technologies  

Developers of a new iPhone application claim their app can analyze a urine specimen for up to 25 different diseases. This mobile app is a deliberate attempt to give consumers the ability to perform diagnostic tests that would normally be run in a full-scale clinical laboratory.

Pathologists and clinical biochemists will want to visit the website of Biosense Technologies to check out this mobile application, which is called uCheck. Biosense is a medical device company located in Mumbai, India. (more…)

FDA Issues Proposed Rule on Medical Device UDI System That Will Also Apply to Clinical Pathology Analyzers and Lab Products

Many products that medical laboratories use will be covered under the new UDI system

You’re reading it here first! UPCs—universal product codes—are coming soon to the medical laboratory analyzers and other products that your clinical laboratory purchases. Under a proposed rule published by the Food and Drug Administration (FDA), medical devices will soon have UDIs—universal device identifiers.

You know about UPCs. Those are the ubiquitous “universal product codes” that are found on literally every retail product. UPCs make scanning at the cash register possible. Now a similar system is coming to medical devices, including the lab analyzers, reagents, and other products used by medical laboratories and pathology. (more…)